Key Dates

Related Announcements

PA-20-261 - PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

PA-20-265 - PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

PA-20-260 - PHS 2020 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

PA-20-262 - PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

Issued by

National Center for Complementary and Integrative Health (NCCIH)

Purpose

The National Center for Complementary and Integrative Health (NCCIH) is committed to the rigorous investigation of mind and body interventions (MBIs) to determine their usefulness and safety. Through this Notice of Special Interest (NOSI), NCCIH supports cutting-edge Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grant applications from small business concerns that will develop and/or validate devices or electronic systems that can: 1) monitor biologically or behaviorally based processes applicable to MBIs or 2) be used in optimizing the practice or increasing the efficacy of MBIs. The applications should: 1) lead to the development of new technologies, 2) adapt existing innovative technologies, devices, and/or electronic systems, 3) repurpose existing devices and electronic systems, or 4) conduct testing of single or combined components of an integrated, long-term, automated, wearable stimulation device or electronic system to monitor or enhance the mechanistic processes or functional outcomes of MBIs. For the purposes of this NOSI, MBIs are nonpharmacologic approaches that include mind/brain focused interventions (e.g., meditation, mindfulness, hypnosis, art/music) or combined mind and body treatment (e.g., acupuncture, massage, spinal manipulation/mobilization) or meditative movement practices (e.g., yoga, tai chi, qi gong).

Background

Studies of MBIs typically comprise three key elements. The first key element is the intervention itself, which commonly involves complex procedures or techniques administered by a trained practitioner, taught by a teacher, or self-taught or administered to improve function and/or to modulate or reduce symptoms (to learn more about MBIs, please see https://www.nccih.nih.gov/health/complementary-alternative-or-integrative-health-whats-in-a-name.). The second key element is the underlying biological or behavioral process by which a given MBI may exert its intended functional change or clinical outcome. The mechanism(s) or process(es) may range widely from biochemical/molecular processes to behavior change. Commonly studied mechanisms of action for MBIs include structural and/or functional changes of physiological systems and networks including parasympathetic and sympathetic neural systems, cortical and subcortical neural networks, neuromuscular systems, the vascular and lymphatic systems, or anti-inflammatory processes. The third key element is the intended functional or clinical outcome for the intervention. Currently, NCCIH-supported extramural MBI research focuses on behavior change and clinical outcomes related to the following high program priority areas:

• Pain management
• Improving sleep and reducing sleep disturbances
• Reducing symptomatic conditions, such as those associated with menopause
• Improving management of mental health conditions commonly managed in primary care, such as mild to moderate depression or anxiety
• Adopting and sustaining healthy behaviors such as healthy eating, smoking cessation, and physical activity.
• Health promotion, disease prevention, health restoration, and resilience

The ultimate goal of many studies of MBIs is to optimize their methods of delivery to maximize efficacy. Such a goal may be accomplished through technological innovation to monitor and possibly facilitate relevant underlying processes associated with these interventions.

Specific Areas of Research Interest

Examples of research topics of interest under this NOSI relevant to a given MBI may include, but are not limited to:

• Development and/or pilot testing of devices to provide biofeedback or for optimizing practice
• Development and/or pilot testing of wireless technologies for real-time data collection and monitoring of brain activity or other physiological signals
• Development or adaptation of biochemical or epigenetic monitoring devices
• Development of electrodermal monitors
• Optimization and pilot testing of an MBI component or parameter to enhance its effect on a proposed mechanism or biological process
• Development or adaptation of technologies to monitor or help optimize breathing for an MBI (e.g., yoga)
• Adaptation of actigraphy devices for an MBI
• Development of sleep monitoring technology
• Development or adaptation of technologies for objective assessment of pain
• Adaptation or development of technologies for home-based delivery of an MBI
• Development and/or pilot testing of systems or devices to measure and promote adherence to the practice of an MBI
• Development and validation of tools, technologies, and instruments, including gaming and virtual reality technologies, for the accurate assessment of adherence and/or fidelity to the use of an MBI
• Development and validation of imaging tools or instruments for studying an MBI
• Development and testing of innovative technologies for multisensory delivery of an MBI.

Scope

This NOSI primarily supports research on various types of MBIs. For the purposes of this NOSI, MBIs are nonpharmacologic approaches that include mind/brain focused interventions (e.g., meditation, mindfulness, hypnosis, art/music) or combined mind and body treatments (e.g., acupuncture, massage, spinal manipulation/mobilization) or meditative movement practices (e.g., yoga, tai chi, qi gong).

Proposed technologies, devices, or electronic systems are expected to target proven or putative mechanisms of an MBI, adherence to MBI practices, or quality of trainer-trainee interactions or other aspects of the approach to either monitor or enhance its effect. A goal of the research should be the commercialization of technology for use by researchers, clinicians, or consumers. Development or adaptation of innovative noninvasive technologies or minimally invasive technologies is preferred.

Devices and technologies developed with the support of this NOSI may be targeted for use across the lifespan (children, adolescents, adults, and elderly), to special populations (e.g., pregnant women, individuals with disabilities), and for a range of social contexts (individuals, family, exercise groups, classroom).

Preclinical testing studies of the proposed technology, device, or electronic system may concentrate on healthy animals or relevant animal models for clinical outcomes of high program priority to NCCIH as described in the section above.

Pilot clinical testing of the proposed technology, device, or electronic system should test its effects on presumed mechanisms or processes as the primary outcomes, and may target healthy populations or a clinical population of high program priority for NCCIH (please see the listing of NCCIH high program priority clinical outcomes in the section above). NCCIH will not support clinical trials aiming to test efficacy/effectiveness (meaning the study is powered on a primary outcome that is a clinical assessment, such as pain, depression, or anxiety) of an intervention as a part of an SBIR phase I or STTR application.

Additional Information for FDA-Regulated Devices

If a device is proposed as part of pilot clinical testing, investigators must contact the U.S. Food and Drug Administration (FDA) prior to submitting an application to determine if an Investigational Device Exemption (IDE) application is necessary for the proposed clinical research.

Application and Submission Information

This notice applies to due dates on or after January 05, 2021 and subsequent receipt dates through January 05, 2024. 

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this Notice.

• PA-20-261 - PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)
• PA-20-265 - PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
• PA-20-260 – PHS 2020 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
• PA-20-262 – PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-AT-21-001” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Scientific/Research Contact(s)

Merav Sabri, Ph.D.

National Center for Complementary and Integrative Health (NCCIH)

Telephone: 301-496-2583

Email: merav.sabri@nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Shelley Carow

National Center for Complementary and Integrative Health (NCCIH)

Phone: 301-594-3788

Email: CarowS@MAIL.NIH.GOV